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In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions, and Paths Forward for In Vitro Model Use
Citation:
Behrsing, H., E. Hill, H. Raabe, R. Tice, S. Fitzpatrick, R. Devlin, K. Pinkerton, G. Oberdorster, C. Wright, R. Wieczorek, M. Aufderheide, S. Steiner, T. Krebs, B. Asgharian, R. Corley, M. Oldham, J. Adamson, X. Li, I. Rahman, S. Grego, P. Chu, S. McCullough, AND R. Curren. In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions, and Paths Forward for In Vitro Model Use. ATLA: Alternatives to Laboratory Animals. Frame, Nottingham, Uk, 45(3):117-158, (2017).
Impact/Purpose:
This is the proceedings and conclusions from a conference focused around the use of novel in vitro approaches to studying inhaled exposures using in vitro models. EPA has committed to reduce the number of animal studies in order to address questions regarding relevance, high cost, and ethical considerations. In order to do so, robust in vitro approaches to elucidate inhaled exposures and how they may lead to pulmonary diseases are needed.
Description:
In 2009, the passing of The Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP) and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed “modified risk”. On 4-6 April 2016, the Institute for In Vitro Sciences, Inc. (IIVS) convened a workshop conference titled “In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products” to bring together stakeholders representing regulatory agencies, academia, and industry to address the research priorities articulated by the FDA CTP. Specific topics were covered to assess the status of current in vitro smoke and aerosol/vapor exposure systems, as well as the various approaches and challenges to quantifying the complex exposures, in in vitro pulmonary models developed for evaluating adverse pulmonary events resulting from tobacco product exposures. The four core topics covered were, 1) Tobacco Smoke And E-Cigarette Aerosols, 2) Air-Liquid Interface-In Vitro Exposure Systems, 3) Dosimetry Approaches For Particles And Vapors; In Vitro Dosimetry Determinations and 4) Exposure Microenvironment/Physiology Of Cells. The two and a half day workshop included presentations from 20 expert speakers, poster sessions, networking discussions, and breakout sessions which identified key findings and provided recommendations to advance these technologies. Here, we will report on the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapor exposures. With the recent FDA publication of the final deeming rule for the governance of tobacco products, there is an unprecedented necessity to evaluate a very large number of tobacco-based products and ingredients. The questionable relevance, high cost, and ethical considerations for the use of in vivo testing methods highlight the necessity of robust in vitro approaches to elucidate tobacco-based exposures and how they may lead to pulmonary diseases that contribute to lung exposure-induced mortality worldwide.
